Medical Devices training courses

This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.

This course helps senior management migrate their system from ISO 13485:2003 to ISO 13485:2016. You will gain a better understanding of your organization’s obligations and develop action plans for managing the transition.

This two-day course has been designed to provide an in depth understanding of ISO 13485:2016. Learn about the various clauses of the standard and understand the implications behind medical devices quality management. Allow our medical devices experts to guide you in unravelling the standard, and bring Medical Devices Quality Management to your organization.

Our Implementing ISO 13485:2016 two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016 certification.

This training course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015 and also it serves to facilitate global alignment for Medical Device quality management systems. 

BSI has developed a short session that makes you aware of what ISO 13485 is, why it is important and how your organization can use it to help maintain patient safety.

This on-demand course will give you an understanding of the key requirements, which will provide:

• Essential knowledge to understand Regulatory Affairs of medical devices in the EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales

Looking for a tutor-led course with peer-to-peer interaction? This course is also available in a virtual or location-based classroom.

Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people.

Looking for a more flexible way to learn? This course is also available on-demand.

Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market. The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators according to their obligations by MDR.

Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and Representative.

Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.

Looking for a more flexible way to learn? This course is also available on-demand.

The IVDR focuses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability. This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

Looking for a tutor-led course with peer-to-peer interaction? This course is also available in a virtual or location-based classroom.

This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization.

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results.

This course is designed to give you insights into how Notified Bodies may perform a MDR QMS compliance audit, using the topics of a typical MDR audit agenda as the basis. This will enable you to optimize your auditing skills and knowledge to boost your audit capabilities, gain confidence in planning and performing an effective EU MDR QMS audit, as well as ensuring continued compliance to the EU MDR (2017/245).

Learn how to implement a risk management framework to achieve ongoing compliance with our two-day course.

Looking for a more flexible way to learn? This course is also available on-demand.

This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745. 

Looking for a tutor-led course with peer-to-peer interaction? This course is also available in a virtual or location-based classroom.

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line with the European Medical Device Regulations (MDR) and ISO 13485:2016 requirements in Europe. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.

This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to:

• Create robust technical documentation to demonstrate compliance to the MDR
• Better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process

This one-day intensive course enables greater understanding of performance evaluation for In Vitro Diagnostic devices, how performance fits into the product development lifecycle and seeks to prepare for future IVD Regulation (IVDR) requirements for clinical evidence.

This one-day intensive course enables greater understanding of the key requirements for technical documentation and design dossiers for IVDs, in line with the European IVD Directive and seeks to prepare for future IVD Regulation (IVDR) requirements in Europe.

This one day course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the European Medical Devices Directive. 

On completion of training, manufacturers will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance to support continuing compliance. 

Learn about the requirements of the European medical device directives (93/42/EEC, 90/385/EEC and 98/79/EC), standards and guidance documents to enable effective implementation of a post-market surveillance system.

This course is designed to provide you with knowledge of how the Medical Device Regulation (MDR (EU 2017/745)), standards and guidance documents impact medical device software; software as a medical device; and medical devices with software.

Learn some key requirements about Annex VII of the MDR and gain a better understanding of why notified bodies may be seen to behave differently and in a much more detailed way than what organisations may have previously experienced.

Learn about the key requirements of risk classification under the MDR, gain a better understanding of the risk classification rules, the need to classify and why the intended purpose of a device is important.

This short course aims to provide you with the key requirements for economic operators within the Medical Device Regulations (MDR). There is now a lot more emphasis on economic operators and their obligations according to the MDR, we’ll be exploring this to give you a better understanding of what this actually means.